FDA.reportPublic FDA data

022x028 AW Tubes-R

Primary DI
D8199000005
Brand
022x028 AW Tubes-R
Company
SPECIALTY APPLIANCES, LLC
Model
900000
Published
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8199000005PackageHIBCC10In Commercial Distribution
D8199000000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106645484
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D81990023903-Part TS Herbst Kit9002392022-11-21
D81990024004-Part Telescoping Herbst Replacement Parts9002402022-11-21
D8199002410Traditional Herbst Replacement Parts9002412022-11-21
D8199512450G4 NiTi Lingual Wire .010 Small Upper9512452025-07-18
D8199512460G4 NiTi Lingual Wire .010 Small Lower9512462025-07-18
D8199512470G4 NiTi Lingual Wire .010 Medium Upper9512472025-07-18
D8199512480G4 NiTi Lingual Wire .010 Medium Lower9512482025-07-18
D8199512490G4 NiTi Lingual Wire .010 Large Upper9512492025-07-18
D8199512500G4 NiTi Lingual Wire .010 Large Lower9512502025-07-18
D8199512510G4 NiTi Lingual Wire .013 Small Upper9512512025-07-18
D8199512520G4 NiTi Lingual Wire .013 Small Lower9512522025-07-18
D8199512530G4 NiTi Lingual Wire .013 Medium Upper9512532025-07-18
D8199512540G4 NiTi Lingual Wire .013 Medium Lower9512542025-07-18
D8199512550G4 NiTi Lingual Wire .013 Large Upper9512552025-07-18
D8199512560G4 NiTi Lingual Wire .013 Large Lower9512562025-07-18
D8199512570G4 NiTi Lingual Wire .016 Small Upper9512572025-07-18
D8199512580G4 NiTi Lingual Wire .016 Small Lower9512582025-07-18
D8199512590G4 NiTi Lingual Wire .016 Medium Upper9512592025-07-18
D8199512600G4 NiTi Lingual Wire .016 Medium Lower9512602025-07-18
D8199512610G4 NiTi Lingual Wire .016 Large Upper9512612025-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611212702BONDING TUBE PREMIUM ROTH 0.018 - U67R (16/17) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213556BONDING TUBE PREMIUM ROTH 0.018 - U67L (26/27) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213587BONDING TUBE PREMIUM ROTH 0.018 - L67L (36/37) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213839BONDING TUBE PREMIUM ROTH 0.018 - L67R (46/47) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
10190886052952AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052969AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052976AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052983AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052990AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053003AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053010AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053027AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053034AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053041AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053058AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053065AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053072AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053089AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053096AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053102AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053119AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053126AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053133AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053140AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053157AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053164AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053171AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053188AGILITYG & H Wire Company, Inc.DZD2025-03-27